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AI-Edigene® BRAF p.K601E (c.1801A>G) Genomic DNA Reference Standard for NGS & PCR QC

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In the era of precision medicine, accurate and reliable detection of oncogenic drivers is fundamental for guiding targeted therapy and prognosis. The BRAF gene is a critical molecule in the MAPK signaling pathway, and its mutation status is vital for the clinical management of various cancers. The BRAF p.K601E mutation, a non-V600E variant, has been identified in multiple solid tumors, including colorectal cancer, lung cancer, and thyroid cancer. To ensure the accuracy and reproducibility of test results, the AI-Edigene® BRAF p.K601E Reference Standard Plus is developed to provide a trusted quality control tool for your tumor genetic testing experiments.
  • CBP10428

  • CBP10428

Availability:


Product Overview
   

The AI-Edigene® BRAF p.K601E Reference Standard Plus is a rigorously validated, genomic DNA (gDNA) reference standard intended for Research Use Only. This product contains a homozygous mutation at the BRAF c.1801A>G locus, resulting in the substitution of lysine (K) for glutamic acid (E) at amino acid position 601 in the encoded serine/threonine-protein kinase B-Raf—the p.K601E mutation.

The BRAF protein is a key member of the Raf family, transmitting signals through the MAP kinase pathway to regulate cell proliferation and growth. BRAF mutations, particularly specific missense mutations like p.K601E, are strongly associated with the pathogenesis and drug resistance of numerous cancers. This standard is designed to provide a stable and homogeneous reference material for the development, validation, calibration, and routine quality control of BRAF p.K601E detection methods (e.g., Next-Generation Sequencing, Sanger Sequencing, digital PCR).


Product Features

 

Well-Defined Genetic Background

DNA Change: c.1801A>G

Amino Acid Change: p.Lys601Glu (p.K601E)

Mutation Type: Missense Substitution

Zygosity: Homozygous, ensuring a clear and strong mutant signal in assays.

Precise Characterization and Traceability:

Allelic Frequency: 100%, providing an ideal benchmark for assessing assay sensitivity and specificity.

Standard Transcript: Based on ENST00000288602, consistent with major databases and clinical guidelines.

Authoritative Database ID: COSMIC ID (COSM478), enabling easy cross-referencing within the internationally recognized cancer mutation database.

Precise Genomic Location: Mapped to chr7:140453134 based on the GRCh37 (hg19) reference genome.

Superior Product Quality

High-Purity DNA: The product is purified genomic DNA supplied in Tris-EDTA buffer, ensuring excellent stability and ready-to-use convenience for downstream applications.

Rigorous Quality Control: Each batch is verified by both DNA electrophoresis and Sanger sequencing, guaranteeing sequence accuracy and integrity. Users can download the Certificate of Analysis (COA) for detailed concentration, purity, and QC data.

Guaranteed Stability: Recommended storage at 2-8°C with a 36-month shelf life, supporting your long-term experimental plans.

 

Product Advantages



Enhanced Assay Reliability: Serves as a perfect positive control to rule out false-negative or false-positive results caused by reagents, instruments, or operational procedures, ensuring the robustness of your detection method.

Facilitates Inter-laboratory Standardization: Using a unified reference standard helps align results across different laboratories and platforms, promoting data integration in multi-center studies.

Optimizes Limit of Detection (LOD): The homozygous genotype makes it an excellent tool for evaluating the sensitivity of detection methods, particularly for assessing low-frequency variant detection capabilities.

Streamlines Workflow: The ready-to-use gDNA format eliminates the need for tedious cell culture or DNA extraction steps, saving valuable research time.

Powerful Traceability: Links to COSMIC and standard transcripts ensure your experimental data is internationally comparable, strengthening the credibility of your research findings.


Usage


Routine QC Implementation

This product is strictly for Research Use Only (RUO) and is primarily applied in the following areas:

Companion Diagnostic Development & Validation: Used for performance parameter confirmation during the R&D phase of IVD test kits.

Laboratory Developed Test (LDT) Validation: Provides calibration and quality control for hospitals and clinical laboratories establishing LDTs such as NGS, qPCR, and dPCR.

Detection Platform Performance Evaluation: Used to assess and compare the accuracy and precision of different sequencing platforms or detection technologies.

Quality Assurance & Proficiency Testing: Serves as an internal control for continuous monitoring of laboratory testing performance.

Basic Research in Cancer Molecular Biology: Used to investigate the specific role of the BRAF p.K601E mutation in tumorigenesis, progression, and drug resistance mechanisms.


Why Choose CB-Gene?


Expertise and Focus: Edigene specializes in the field of molecular diagnostic standards, with a deep understanding of the importance of accurate detection for clinical and research applications.

Rigorous Quality Control System: Every step, from raw material selection to the final product, undergoes strict QC verification, supported by a traceable COA for your peace of mind.

Technological Foresight: Product design keeps pace with industry guidelines and database updates (e.g., GRCh37/hg19), ensuring compatibility with mainstream bioinformatics pipelines.

Excellent User Experience: Clear product information, easy access to COA downloads, stable product supply, and comprehensive customer support to fully enable your research.


FAQ

 

What is the zygosity of this reference standard?

This product is Homozygous, with a 100% allele frequency. This means all DNA molecules carry the c.1801A>G mutation at this locus.

Which detection technologies is this standard suitable for?

It is widely applicable to various DNA-based mutation detection technologies, including but not limited to Sanger Sequencing, Next-Generation Sequencing (NGS), digital PCR (dPCR), ARMS-PCR, and Pyrosequencing. It is an ideal tool for validating these technologies' ability to detect the BRAF p.K601E mutation.

In what form is the product delivered and how should it be stored?

The product is supplied as Genomic DNA dissolved in Tris-EDTA Buffer. Upon receipt, briefly centrifuge the tube and store it at 2-8°C. Avoid repeated freeze-thaw cycles to maintain DNA integrity.

Can I use this standard for clinical diagnosis?

No. This product is clearly labeled "For Research Use Only" and is not intended for use in clinical diagnosis, therapeutic decision-making, or any other clinical applications.

Where can I find the product's concentration and quality control data?

Each vial comes with a dedicated Certificate of Analysis (COA). You can download the corresponding COA using the information on the product packaging or by contacting our sales team. The COA details the batch-specific concentration, purity (A260/A280 ratio), and QC results from DNA electrophoresis and sequencing.

 

Product Information

AI-Edigene® BRAF p.K601E Reference Standard Plus

Catalog No.

CBP10428

Format

Genomic DNA

Intended Use

Research Use Only

Unit Size

1ug

Sanger sequencing

CBP10428

Storage

2~8°C

Expiry

36 months from the date of manufacture


Technical Data

Product Information

AI-Edigene® BRAF p.K601E Reference Standard Plus

DNA Change

c.1801A>G

AA Change

p.K601E

Mutation type

Substitution - Missense

Zygosity

Homozygous

Allelic Frequency

100%

Transcript

ENST00000288602

Cosmic ID

COSM478

Chr position(GRCh37)

chr7:140453134

Buffer

Tris-EDTA

 

Related product list


Name

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Details

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COA Download:CBP10428 CBFA23081701X

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If you have any questions, please feel free to contact us at sales@cb-gene.com




General Information

Product Information

AI-Edigene® BRAF p.K601E Reference Standard Plus

Catalog No.

CBP10428

Format

Genomic DNA

Intended Use

Research Use Only

Unit Size

1ug

Sanger sequencing

CBP10428

Storage

2~8°C

Expiry

36 months from the date of manufacture



Detailed Data

Product Information

AI-Edigene® BRAF p.K601E Reference Standard Plus

DNA Change

c.1801A>G

AA Change

p.K601E

Mutation type

Substitution - Missense

Zygosity

Homozygous

Allelic Frequency

100%

Transcript

ENST00000288602

Cosmic ID

COSM478

Chr position(GRCh37)

chr7:140453134

Buffer

Tris-EDTA



Related product list


Name

Catalog No.

Details

AI-Edigene® BRAF p.K601E Reference Standard Plus

CBP10428

COA Download:CBP10428 CBFA23081701X

AI-Edigene® BRAF p.V600D Reference Standard Plus

CBP10423

COA Download:CBP10423 CBFA23033005X

AI-Edigene® BRAF p.V600E Reference Standard Plus

CBP10424

COA Download:CBP10424 CGFA23050509

AI-Edigene® BRAF p.V600G Reference Standard Plus

CBP10427

COA Download:CBP10427 CBFA23030703X

AI-Edigene® BRAF p.V600K Reference Standard Plus

CBP10413

COA Download:CBP10413 GBD42749765

AI-Edigene® BRAF p.V600M Reference Standard Plus

CBP10425

COA Download:CBP10425 CGFA23050618

AI-Edigene® BRAF p.V600R Reference Standard Plus

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COA Download:CBP10426 CGFA23040403

BRAF p.G464V Reference Standard

CBP10695

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COA Download:CBP10242 CBFA22101479

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COA Download:CBP10237 CBFA23062104

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If you have any questions, please feel free to contact us at sales@cb-gene.com



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